<Co>rapporteur day <60*>80 critical assessment report

*in case of accelerated assessment for procedures starting from September 2016 onwards

Assessment report on the claim of new active substance (NAS) status of <active substance> contained in <product name>

International non-proprietary name: <INN>

Procedure no.: EMEA/H/C/<XXX>

Applicant:

Rapporteur:
Co-rapporteur:
EMA PTL:
Start of the procedure:
Date of this report:
Deadline for comments:

Table of contents

1. Recommendation

2. Executive summary

2.1. Problem statement

3. Scientific evaluation

3.1. <Quality aspects>

Discussion on quality aspects

Conclusions on quality aspects

3.2. <Non-clinical aspects>

Discussion on non-clinical aspects

Conclusions on non-clinical aspects

3.3. <Clinical aspects>

Discussion on clinical aspects

Conclusions on clinical aspects

4. Overall conclusions

5. List of questions

Administrative information

Name of the medicinal product:
Applicant:
Active substance:
International Nonproprietary Name/Common Name:
Pharmaco-therapeutic group
(ATC Code):
Therapeutic indication(s):
(Co-)Rapporteur’s contact person:
Names of the (Co)Rapporteur assessors (internal and external): / Name(s):
Tel:
Fax:
e-mail:

Declarations

The assessor confirms that proprietary information on, or reference to, third parties (e.g. ASMF holder) or products are not included in this assessment, unless there are previous contracts and/or agreements with the third party(ies).

The assessor confirms that reference to ongoing assessments or development plans for other products is not included in this assessment report.

Whenever the above box is un-ticked please indicate section and page where confidential information is located here:

1. Recommendation

Based on the review of the data the <Co->Rapporteur considers that the active substance <active substance> contained in the medicinal product <product name>

<is to be qualified as a new active substance <in itself.> <in comparison to the known <isomer/mixture of isomers/complex /derivative/salt of {INN (salt) approved} previously authorised in the European Union as <active substance> it differs significantly in properties with regard to safety and efficacy from the previously authorised substance.>

<could be qualified as a new active substance <in itself> <in comparison to the known <isomer/mixture of isomers/complex /derivative/salt of {INN (salt) approved} previously authorised in the European Union as {name of the medicinal product approved}> <provided that satisfactory responses are given to the concerns as detailed in the List of Questions>

<is not to be qualified as a new active substance <in itself.> <in comparison to the known <isomer/mixture of isomers/complex /derivative/salt of {INN (salt) approved} previously authorised in the European Union as {name of the medicinal product approved} as it does not differ significantly in properties with regard to safety and efficacy from the previously authorised substance.> The concerns identified, which preclude the recommendation are detailed in the List of Questions.>

2. Executive summary

2.1. Problem statement

This application was submitted in accordance with Article 8(3) of Directive 2001/83/EC and it contained evidence and discussion as to why the active substance <active substance> should be regarded as new.

The applicant requested the active substance <active substance> contained in the above medicinal product to be considered a new active substance <in itself.> <in comparison to the known <isomer/mixture of isomers/complex /derivative/salt of {INN (salt) approved} previously authorised in the European Union as {name of the medicinal product approved}, and claimed that <active substance> differs significantly in properties with regard to safety and efficacy from the already authorised substance.>

3. Scientific evaluation

3.1. Quality aspects

Discussion on quality aspects

Conclusions on quality aspects

3.2. Non-clinical aspects

Discussion on non-clinical aspects

Conclusions on non-clinical aspects

3.3. Clinical aspects

Discussion on clinical aspects

Conclusions on clinical aspects

4. Overall conclusions

For opinions where further information should be provided by the applicant

< Based on the review of data on the quality, non-clinical and clinical properties of the active substance, the <Co->Rapporteur considers that further evidence should be provided by the applicant to substantiate the claim that <active substance> is to be qualified as a new active substance. Satisfactory answers must be given to the concerns as detailed in the List of Questions.>

For opinions where no further information should be provided and where the applicant claimed that the compound is a new active substance in itself

<Based on the review of data on the quality, non-clinical and clinical properties of the active substance, the <Co->Rapporteur considers that <active substance> is <not> to be qualified as a new active substance.>

For opinions where no further information should be provided and where the applicant claimed that the compound is a new active substance in comparison to a known isomer/mixture of isomers/complex /derivative/salt of a chemical substance previously authorised as a medicinal product in the European Union

<Based on the review of data on the quality, non-clinical and clinical properties of the active substance, the <Co->Rapporteur considers that <isomer/mixture of isomers/complex /derivative/salt of> {INN (+salt) applicant} in comparison to the known <isomer/mixture of isomers/complex /derivative/salt of> {INN (salt) approved} is <not> to be qualified as a new active substance as it <differs<does not differ> significantly in properties with regard to safety and efficacy from the previously authorised substance.>

5. List of questions

<Not applicable>

<Co>rapporteur day <60*<80> critical assessment report
Assessment report on the claim of new active substance (NAS) status of <active substance> contained in <product name>
Rev10.16 / Page 1/5